Study on Rectal Cancer Treatment with Radiotherapy, Atezolizumab, and Bevacizumab for Patients with Low- to Intermediate-Risk

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What is this study about?

This clinical trial is focused on studying the effects of a treatment for rectal cancer, a type of cancer that affects the last part of the large intestine. The treatment being tested involves a combination of two medications, atezolizumab and bevacizumab, which are given after a course of radiotherapy. Atezolizumab, also known by its code name RO5541267, and bevacizumab are both administered as solutions for infusion, meaning they are given directly into the bloodstream through a vein.

The purpose of the study is to explore how effective this combination treatment is for patients with low- to intermediate-risk rectal cancer. Participants will first receive radiotherapy, which uses high-energy rays to target and kill cancer cells. After completing radiotherapy, they will receive the medications atezolizumab and bevacizumab. The study will monitor the participants’ response to the treatment over a period of time, looking for signs of improvement or changes in the cancer.

Throughout the study, participants will undergo various assessments to track their health and the cancer’s response to the treatment. These assessments may include imaging tests like MRI (Magnetic Resonance Imaging) to visualize the tumor and check for any changes. The study aims to determine if this treatment approach can help achieve a complete or near-complete response in the cancer, potentially allowing for organ preservation and reducing the need for more invasive treatments. The trial will also monitor the safety of the treatment and any side effects that may occur.

1 joining the study

Upon joining the study, you will be required to sign an informed consent form. This document confirms your understanding of the study and your agreement to participate.

If you are a woman of childbearing potential, a negative pregnancy test is required within 14 days before starting the study. You must agree to use effective birth control methods during the study and for at least 180 days after the last treatment.

2 initial assessments

You will undergo a series of initial assessments, including a proctoscopy and biopsies. These procedures help in evaluating your condition before starting the treatment.

Your overall health and ability to comply with the study protocol will be assessed. This includes checking your performance status and ensuring you have adequate blood and organ function.

3 radiotherapy

The first phase of treatment involves receiving radiotherapy. This is a standard treatment for rectal cancer and aims to reduce the size of the tumor.

4 atezolizumab and bevacizumab treatment

Following radiotherapy, you will receive two medications: atezolizumab and bevacizumab. Both are administered as solutions for infusion, meaning they are given through a vein.

Atezolizumab is provided as a 1,200 mg dose, and bevacizumab is given as a 25 mg/ml dose. The frequency and duration of these treatments will be determined by the study protocol.

5 monitoring and follow-up

Throughout the study, your response to the treatment will be closely monitored. This includes regular check-ups and imaging tests to assess the tumor’s response.

At week 12 after radiotherapy, a primary assessment will be conducted to evaluate the clinical response to the treatment.

6 completion of study

Upon completion of the study, further evaluations will be conducted to determine the overall effectiveness of the treatment and any long-term effects.

You will be informed about the results and any necessary follow-up care or additional treatments.

Who Can Join the Study?

Signed informed consent form.
For women who can have children: A negative pregnancy test within 14 days before starting the study. Agree to avoid pregnancy by not having heterosexual intercourse or using very effective birth control during the study and for at least 180 days after the last treatment.
For men: Agree to avoid fathering a child by not having heterosexual intercourse or using birth control, and agree not to donate sperm.
Must be at least 18 years old.
Able to follow the study rules, as judged by the study doctor.
Confirmed diagnosis of adenocarcinoma of the rectum (a type of rectal cancer).
Have intermediate-risk rectal cancer (specific stages of cancer) or low-risk rectal cancer and wish to try to preserve the organ.
Willing to have a proctoscopy (a procedure to look inside the rectum) and biopsies (taking small samples of tissue) before and during treatment at specific times.
Have an ECOG Performance Status of 0 or 1, which means you are fully active or have some symptoms but can carry out light work.
Have a disease that can be measured according to international guidelines for rectal cancer imaging.
Have adequate blood and organ function, as shown by specific laboratory test results taken within 14 days before starting the study treatment. This includes:
- ANC (a type of white blood cell) at least 1.5 x 10⁹/L without support.
- Platelet count at least 100 x 10⁹/L without transfusion.
- Hemoglobin at least 5.6 mmol/L (transfusions allowed to meet this level).
- AST, ALT, and ALP (liver enzymes) no more than 2.5 times the upper limit of normal.
- Serum bilirubin no more than 1.5 times the upper limit of normal, except for those with Gilbert disease, where it should be no more than 3 times the upper limit.
- Serum creatinine no more than 1.5 times the upper limit of normal or creatinine clearance at least 40 mL/min.
- Serum albumin at least 25 g/L.
- For those not on blood thinners: INR or aPTT no more than 1.5 times the upper limit of normal. Those on blood thinners must be on a stable regimen.

Who Cannot Join the Study?

Patients with any other type of cancer besides rectal cancer cannot participate.
Patients who have had previous treatment with the study drugs atezolizumab or bevacizumab are not eligible.
Patients with severe allergies to any of the study drugs or their ingredients cannot join the study.
Patients with serious heart conditions, such as heart failure or recent heart attack, are excluded.
Patients with uncontrolled high blood pressure are not allowed to participate.
Patients with active infections, including HIV, hepatitis B, or hepatitis C, cannot take part in the study.
Patients who are pregnant or breastfeeding are not eligible.
Patients with autoimmune diseases, which are conditions where the immune system attacks the body, are excluded.
Patients who have had an organ transplant cannot participate.
Patients with a history of bleeding disorders or who are taking blood thinners are not eligible.
Patients with a history of brain conditions, such as seizures or stroke, are excluded.
Patients who are participating in another clinical trial at the same time are not allowed to join.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Stichting OLVG	Amsterdam	The Netherlands

Other Sites

Site Name	City	Country	Status
Netherlands Cancer Institute	Amsterdam	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Recruiting	01.09.2019

Trial locations

Investigated drugs:

Atezolizumab is a type of medication known as an immunotherapy. It works by helping your immune system recognize and attack cancer cells. In this trial, atezolizumab is used after radiotherapy to help your body fight rectal cancer more effectively.

Bevacizumab is a medication that targets the blood vessels that supply nutrients to tumors. By blocking these blood vessels, bevacizumab can help slow down or stop the growth of cancer. In this trial, it is used alongside atezolizumab after radiotherapy to enhance the treatment of rectal cancer.

Investigated diseases:

Colorectal cancer

Rectal cancer – Rectal cancer is a type of cancer that begins in the rectum, which is the last several inches of the large intestine before the anus. It typically starts as a growth on the inner lining of the rectum, known as a polyp, which can become cancerous over time. As the disease progresses, the cancer cells can invade deeper layers of the rectal wall and potentially spread to nearby lymph nodes and other organs. The progression of rectal cancer can lead to symptoms such as changes in bowel habits, rectal bleeding, and abdominal discomfort. The disease may continue to advance if not managed, affecting the function of the rectum and surrounding tissues.

Trial ID:

2024-517119-59-00

Protocol code:

N18TRZ

NCT ID:

NCT04017455

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Rectal Cancer Treatment with Radiotherapy, Atezolizumab, and Bevacizumab for Patients with Low- to Intermediate-Risk

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?